COVID taught us that you can never tell when the next simple diagnostic kit for communicable disease will become the most sought-after product on the market.
On-the-spot, cost-effective diagnostics are lifesavers, but they also give policymakers and number crunchers the data needed to make large-scale public health decisions – that’s something else we can thank the pandemic for.
Speedy point-of-care diagnostics
Recognising this, Australian biotech Lumos Diagnostics Holdings Ltd (ASX:LDX, OTC:LDXHF) specialises in rapid, reasonably priced and complete point-of-care diagnostic test solutions to assist medical professionals more accurately diagnose and manage medical conditions.
The company is cornering the market in customised assay development and manufacturing services for point-of-care tests and proprietary digital reader platforms.
It also runs a range of proprietary point-of-care diagnostics that it develops, manufactures and commercialises in-house, targeting infectious and inflammatory diseases, with an emerging focus on women’s health.
Combatting antibiotic resistance
One of the biggest public health threats on the horizon in the past few decades has been antimicrobial resistance (AMR).
This has been caused, in part, by the overprescription of antibiotics for illnesses that have a viral basis – which means the antibiotics are unnecessary and are contributing to the problem of AMR.
AMR is already contributing to hundreds of thousands of deaths around the world and this challenge is only going to get thornier over time, as superbugs continue to defy the existing treatments we have.
It can be difficult to diagnose whether an infection is bacterial or viral because the symptoms are remarkably similar.
This is particularly true for widespread complaints such as colds, sore throat, fever, cough, congestion and a runny nose, which are some of the most common reasons patients seek out medical advice and antibiotics. Most of these are caused by viruses and cannot be eased by antibiotics.
Nevertheless, health professionals are prescribing them for non-bacterial infections in almost 50% of cases, flooding the environment with antibiotics that exacerbate the issue of resistance to them over time.
The proper diagnosis of a viral infection will help medical professionals assess and prioritise patients who need pathogen-specific testing and reduce unnecessary antibiotic prescriptions and the spread of antibiotic-resistant bacteria.
Another plank of Lumos’ philosophy is that, where possible, patients with viral infections should be cohorted appropriately to reduce the spread of infection – and accurate detection is key to this.
In this context, Lumos is working to bring two simple tests to market to help health professionals spare the antibiotics and give patients the appropriate care.
Enter FebriDx and ViraDx
Flagship diagnostic FebriDx, a rapid point-of-care test using a fingerstick blood sample, takes 10 minutes to let a health professional know, in a timely and targeted way, if an antibiotic is required.
This all-in-one, instrument-free test uses a highly sensitive and specific dual biomarker technology to provide reliable results.
The absence of heavy equipment means the test is inexpensive and fully portable, while the speed of diagnosis cuts the costs of multiple patient visits.
The test has a 99% negative predictive value (NPV) for ruling out bacterial infection.
Use of this diagnostic at an appointment can give health professionals confidence in their diagnosis, fostering appropriate patient management and eliminating inappropriate antibiotic prescriptions.
Lumos is targeting an upcoming Clinical Laboratory Improvement Amendment (CLIA) waiver trial for FebriDx, into which it is hoping to channel up to A$10 million in capital-raised funds.
A successful outcome for the trial would significantly expand the US market for FebriDx, multiplying its potential customer base by over 15 times.
Lumos is also bringing to market ViraDx, a rapid point-of-care test for COVID and flu (A/B), which received emergency use authorisation (EUA) in the US in September 2023.
Solid financials
In the 2024 fiscal year, Lumos reported revenue of US$11.1 million, a 6% increase over the prior year.
The company achieved positive net operating cash flow of US$0.9 million while its adjusted EBITDA loss stood at US$3.9 million, which represented a 28% improvement from the previous year. Lumos closed out the 2024 financial year with US$6.5 million in cash reserves.
Beyond FebriDx and ViraDx, Lumos continues to build momentum in its commercial services division, which generated US$9.9 million in revenue.
A strategic partnership with Hologic, centred on their fFN test, is expected to contribute US$14.7 million in future value. In addition, Lumos has a pipeline of commercial services projects across the health, veterinary, food safety and molecular diagnostics sectors.
The company is also exploring diagnostic solutions in women's health, aiming to address the growing demand for rapid, on-site testing solutions for common infections.